FDA OKs marketing of contraceptive app

The Natural Cycles app has generated controversy in Europe, where women have reported unplanned pregnancies while using it.

By Susan Kelly • Aug. 13, 2018

Burn treatment earns expanded compassionate use approval

The suspension offers a way to achieve permanent closure in burns and other wounds while reducing the amount of skin harvested at the time of surgery.

By Susan Kelly • Aug. 10, 2018

Explore the Trendline➔

Top 5 stories from MedTech Dive

From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.

By MedTech Dive staff

TGA seeks industry input on cybersecurity, medtech software guidance

The agency has commissioned reports to inform approaches that support companies and protect patients.

By Nick Paul Taylor • Aug. 10, 2018

FDA warns overreliance on membrane tests could up fetal death risk

The rupture test results could be misinterpreted, leading to serious adverse events.

By Nick Paul Taylor • Aug. 9, 2018

UnityPoint's second data breach this year could prompt expanded lawsuit

The Des Moines-based nonprofit notified 1.4 million people last week that a phishing attack may have compromised their information.

By Meg Bryant • Aug. 8, 2018

Regs, patient perceptions threaten to throttle neuromodulation growth

Analysts think electrical stimulation devices may struggle to fulfill their commercial potential, challenging the perception that they will soon address a range of unmet neurological medical needs.

By Nick Paul Taylor • Aug. 8, 2018

CMS' Verma stands firm on 2015 EHR deadline, move to open APIs

Meanwhile, the coalition Health IT Now sent a letter to ONC chiding the government for failing to implement information blocking provisions of the 21st Century Cures Act.

By Meg Bryant • Aug. 7, 2018

UK regulators reassure medtech sector about Brexit impact

The MHRA expects little to change until 2021 but the risk of significant near-term upheaval remains.

By Nick Paul Taylor • Aug. 7, 2018

FCC seeks comments on $100M telehealth pilot

The commission noted many low-income consumers, especially in rural areas, lack access to affordable or adequate broadband.

By Susan Kelly • Aug. 6, 2018

NIST offers 'how to' for securing EHRs on mobile devices

Such devices are ubiquitous in healthcare, raising concerns about security and privacy of personal health information.

By Meg Bryant • Aug. 3, 2018

Abbott device to treat Parkinson's now MRI-compatible

Medtronic's deep brain stimulation system was approved in 2002 to treat advanced Parkinson's disease. Abbott acquired its system through its purchase of St. Jude.

By Susan Kelly • Aug. 3, 2018

CMS clears payment for Boston Scientific's newly bought Sentinel

The ruling by the agency was a reversal from an earlier draft and came the day BSX closed its buy of Claret Medical, which makes the device.

By Kerry Dooley Young • Aug. 3, 2018

Industry urges Congress to ease clinical lab pay cuts

The medical device and hospital industries are among those arguing that under the first six months of new reimbursement rates, labs have cut staff, resulting in limited or ended home care visits for homebound patients.

By David Lim • Aug. 3, 2018

EMA faces higher staff losses ahead of move to Amsterdam

The regulator is putting business continuity plans in place, as it expects to lose up to a third of its workforce.

By Suzanne Elvidge • Aug. 2, 2018

Baxter gets CE mark for Evo IQ smart infusion pump

The clearance marks the start of a series of planned regulatory submissions for the device, which will potentially compete with those made by rivals B. Braun and BD.

By Nick Paul Taylor • Aug. 2, 2018

FDA approves Medtronic implant for rare form of hypertension

United Therapeutics will lead commercial promotion of the system, which delivers the drug Remodulin.

By Susan Kelly • Aug. 1, 2018

Industry balks at FDA's cybersecurity plans

"We already know that FDA will reject premarket submissions if they do not follow the cybersecurity guidance," AdvaMed's Zach Rothstein said.

By Meg Bryant • Aug. 1, 2018

Patients often choose higher-cost locations for MRIs, study finds

Referring physicians have more influence over a patient's decision than out-of-pocket costs, according to the report from the National Bureau of Economic Research.

By Les Masterson • July 31, 2018

FDA warns about vaginal 'rejuvenation' device claims

The seven device makers notified by FDA are Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton and Thermigen.

By Susan Kelly • July 31, 2018

Conservative think tank praises CMS proposal on DME bidding

The industry-funded Pacific Research Institute contends that the current bidding system is driving suppliers out of the market and creating supply shortages. The proposal could increase costs to Medicare.

By David Lim • July 31, 2018

MedTech Europe seeks 'urgent' changes to EU regs deadlines

The trade group proposes either stopping the clock on the countdown to the end of the transition periods or delaying the implementation dates for all products, or just legacy products. 

By Nick Paul Taylor • July 31, 2018

Gottlieb teases guidance on continuous trials, touts surrogate endpoints

In a self-described "tweetorial," the FDA chief said modernizing clinical trials could help cut costs.

By Lisa LaMotta • July 30, 2018

FDA approves Abbott's blood sugar sensor for 14-day use

The system was the first continuous glucose monitor to eliminate the need for routine finger prick tests. 

By Susan Kelly • July 30, 2018

FDA sets 2019 medical device user fee rates

The agency said the base fee for a premarket application received during FY 2019 is $300,000 with the base fee for an establishment registration at $4,548.

By Susan Kelly • July 30, 2018

CMS advisers split on procedure volume rules for TAVR

Edwards LifeSciences and Medtronic offered different takes on the current coverage policy.

By Susan Kelly • July 30, 2018